PhD Physics, MSc Medical Physics · Manager Regulatory Affairs – Medical Devices
Anne-Sophie is a Regulatory Affairs leader with over two decades of experience in medical physics, diagnostic imaging, and medical device regulation. She supports clients navigating EU MDR, FDA, and international regulatory frameworks.
Successful MedTech companies treat product development as a lifecycle strategy. Learn why regulatory planning, IP strategy and development must evolve together.
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Developing Software as a Medical Device under EU MDR requires clear intended use, risk classification under Rule 11, and compliance with IEC 62304. Learn what SaMD developers need to know.
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IP strategy should start early in MedTech development. Discover how patent strategy, regulatory classification, and product development influence IP protection for emerging MedTech companies.
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EU MDR compliance can be challenging for emerging MedTech companies. Learn what MDR actually requires, from qualification and QMS to technical documentation and post-market obligations.
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Many MedTech startups treat IP and regulatory strategy as separate disciplines. Discover the three most common mistakes and how aligning both early strengthens market access and product value.
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¿Es tu producto un producto sanitario? Depende de los mercados en los que quieras entrar y de su normativa. He aquí un resumen para orientarte.
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Los términos SaMD (Software as a Medical Device) y MDSW (Medical Device SoftWare) a menudo se usan indistintamente dentro de los entornos médicos, pero no lo son. Conoce la diferencia de significado y alcance regulatorio aquí..
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Cada dispositivo médico individual debe tener un Identificador Único de Dispositivo (UDI) con su portador (código de barras o código QR). Pero, ¿qué pasa con el software de dispositivos médicos? ¡Lee la respuesta en este artículo!
Read moreEach medical device needs a Unique Device Identifier (UDI) with a barcode or QR code. But what about medical device software? Find out in this article!
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The introduction of MDR impacts CE-marked medical software (MDSW). Curious about the scope of this impact on your software? Read more here.
Read moreThe terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not. Learn the difference in meaning and regulatory scope here.
Read moreIs your product a medical device? Well, that depends on the markets you want to enter and their regulations. Here's an overview to guide you.
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